Quality Manager II, Combination Products & Medical (all genders) (fulltime, regular)

Welcome to AbbVie! As part of an international company with ca. 57,000 employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place! Together, we break through – as  Quality Manager II, Combination Products & Medical (all genders) The Quality Manager II Combination Products & Medical is responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed, manufactured, tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations. Make your mark: • Assure proper integration and support of device, drug and biologics regulations. • Lead product team members through the design process providing guidance while working closely with research organizations to ensure potential product issues are identified and addressed to ensure robust product requirements. • Ensure design control documentation as well as design change control requirements are met by assessing the impact of a change on the safety, efficacy of the combination product/device. • Perform 3rd party supplier management while reviewing and approving supplier design control activities, assess supplier changes, provide input to quality agreements, and maintain appropriate balance between internal oversight actions and supplier controls. • Partner with third party vendors, manufacturers and laboratories to ensure that combination products/devices follow internal and regulatory agency standards, including supplier site visits and support of supplier audits. • Foster close global collaboration with R&D, Operations and Commercial Operation functions to identify and mitigate product risks while performing risk assessment of changes on safety and efficacy, utilizing risk control tools such as FMEA. • Identify gaps in existing processes as well as the need for new processes in the cross-functional collaboration. • Guide project development in global and local product development teams to proactively address quality-related issues, advise internal business partners and cross-functional groups on QA expertise as well as medical device/combination product regulations. This is how yo make a difference: • Bachelor’s degree in biomedical engineering, mechanical engineering, or another relevant technical or scientific discipline. • Minimum 6+ years of industry experience in Quality Assurance, development or healthcare related field. Medical device experience required. Combination Product and 3rd party supplier management experience preferred. Less experience considered with advanced degree. • Understanding of regulations and standards affecting combination products and medical devices required. Must have negotiation skills and have been seen to take a position on Quality issues and standards and must be capable of clearly and logically justifying such positions. • Sound technical understanding of product development (e.g. approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control. • Well-versed in risk management methodologies and their application. • Able to take the initiative to identify and implement new approaches to resolve problems, able to challenge scientific arguments - strong analytical approach to identify problem area